Robotic Surgery of the Ocular Surface

Pterygium Clinical Trial

Official title:

Robotic Microsurgery of the Ocular surfaceProspective Human Feasibility Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02116062
• Other study ID #: 5540
• Status: Terminated
• Phase: N/A
• Start date: June 2014
• Est. completion date: April 2018

Study information

• Verified date: August 2019
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The introduction of surgical robots in the OR revolutionized a number of specialties (i. e. urology, gynecology, digestive surgery). Robots are currently used in many situations and the list of appropriate indications is growing rapidly. There are many potential advantages of robotics in eye surgery such as increased precision and maneuverability, better ergonomics, improved patient access to surgeons and surgical training. As a result, robotics might improve patient care. The Da Vinci© robot has been used for 10 years in experimental conditions to suture corneal lacerations, to perform corneal grafts, to remove ocular foreign bodies, lens capsules and vitreous. The authors reported a lack of precision resulting from poor visualization and the absence of microsurgical instruments. These elements were considered to be hurdles to further clinical investigation. The new Da Vinci Si HD© robot has been available since 2009 at the IRCAD center and more recently in Strasbourg University Hospital. It provides greater magnification and better resolution of the operative field than the previous model. We performed since 2012 various ocular surface surgeries on porcine eyes at the IRCAD center. The aim of the present trial is to perform the same procedures (amniotic membrane transplantations, pterygium surgeries, corneal grafts) in a clinical setting with the Da Vinci Si HD© system.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patient > 18 year-old suffering :

symptomatic pterygium

• chronic corneal ulceration resistant to medical treatment

• corneal opacity involving corneal stroma and corneal endothelium

• corneal thinning

• corneal perforation

Exclusion Criteria:

• History of eye surgery

• psychiatric disease

• mental deficiency

• pregnancy

• nursing mother

Related Conditions & MeSH terms

• Corneal Opacity
• Corneal Opacity Corneal Thinning
• Corneal Perforation
• Keratitis
• Pterygium

Intervention

Device:
• 1. Amniotic membrane transplantation on the cornea with the Da Vinci Si HD© robot (Inlay or overlay technique)

• Pterygium removal and autograft of the conjunctiva with the Da Vinci Si HD© robot (Kenyon technique)

• Penetrating keratoplasty using Baron trephine and nylon stitches with the Da Vinci Si HD© robot

Locations

Country	Name	City	State
France	Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respect for different phases of the operating procedure of each intervention.	Surgeons will check that all steps of the surgery have been done and successfully completed (thanks to a surgery ckeck-list procedure and video tape)	At the end of the surgery